Stabilization Devices for Vascular Access and Methods of Using the Same

ABSTRACT

A stabilization device configured to stabilize an access device when a distal end portion of the access device is inserted through a target location of a patient. The stabilization device includes a coupling surface, a proximal surface, and a base surface. The coupling surface is configured to be placed in contact with an adapter coupled to a proximal end portion of the access device. The proximal surface forms at least one angle and is configured to facilitate securement of the stabilization device to the target location. The base surface forms a contoured portion configured to be placed in contact with the target location and a recessed portion configured to be spaced apart from the target location. The stabilization device is configured to be secured to the target location such that the adapter is retained in a fixed position relative to the coupling surface and the access device is stabilized.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/992,661 entitled “Stabilization Devices for Vascular Access andMethods of Using the Same”, filed May 30, 2018, which claims priority toU.S. Provisional Patent Application Ser. No. 62/512,332 entitled,“Stabilization Devices for Vascular Access and Methods of Using theSame”, filed May 30, 2017, the disclosures of each of which areincorporated herein by reference in its entirety.

BACKGROUND

The embodiments described herein relate generally to medical devicesand, more particularly, to devices and methods for stabilizing vascularaccess devices such as intravenous catheters and/or extension sets.

Many medical procedures and/or surgical interventions include insertingan access device or fluid transfer device into a portion of the body.For example, catheters and/or other lumen-defining devices can beinserted into and/or through vascular structures to access portions ofthe body or to transfer fluids from or to a patient. In some instances,vascular access devices (VADs) such as, for example, peripheralintravenous catheters (PIVs), are inserted into patients (e.g., when apatient is hospitalized or during other medical procedures) and aredesigned and/or intended to remain within the patient for an extendedperiod.

VADs typically include a catheter formed from a soft bio-reactivepolymer that is partially disposed in the body and that is attached, ata proximal end (e.g., the end outside of the body) to a hub, which inturn, can provide an interface for attaching any suitable device. Afterplacing the VAD (e.g., a PIV catheter or the like) within a vein (orartery) of the patient, it is often desirable to stabilize and/or securethe VAD relative to the patient. For example, in some instances,movement of the VAD relative to the patient can result in undesirablebending, flexing, and/or kinking of the catheter. In other instances,movement of the VAD (e.g., along a longitudinal axis of the VAD) canwithdraw a portion of the catheter from the patient's body, which inturn, can expose that portion of the catheter to an unsterileenvironment. Moreover, moving the VAD back to its original position candisposed the potentially contaminated portion of the VAD catheter in thepatient, thereby increasing the chances of infection.

Stabilizing and/or securing devices are often used in an effort tominimize movement of a placed or indwelling VAD (e.g., PIV catheter).Some known stabilizing and/or securing devices, however, are complicatedand/or time consuming to use, while others may provide inadequatestabilization. In addition, the shape and/or configuration of some knownstabilizing and/or securing devices can negatively impact a flow ratethrough a portion the VAD and/or the vein (or artery) in which thecatheter is disposed.

Thus, a need exists for improved devices and methods for stabilizingplaced vascular access devices.

SUMMARY

Devices and methods for stabilizing placed or indwelling vascular accessdevices such as, for example, intravenous or arterial catheters aredescribed herein. In some embodiments, an apparatus includes astabilization device configured to stabilize an access device when adistal end portion of the access device is inserted through a targetlocation of a patient and at least partially disposed within a portionof the patient. The stabilization device can include a coupling surface,a proximal surface, and a base surface. The coupling surface isconfigured to be placed in contact with an adapter coupled to a proximalend portion of the access device. The proximal surface forms at leastone angle and is configured to facilitate securement of thestabilization device to the target location of the patient. The basesurface forms a contoured portion configured to be placed in contactwith the target location and a recessed portion configured to be spacedapart from the target location when the contoured portion is in contactwith the target location. The stabilization device is configured to besecured to the target location of the patient such that (1) the adapteris retained in a fixed position relative to the coupling surface and (2)the access device is stabilized relative to the target location.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 are a rear schematic illustration and a right-sideschematic illustration, respectively, of a stabilization deviceaccording to an embodiment.

FIGS. 3-6 are various views of a stabilization device according to anembodiment.

FIG. 7 is a top view of the stabilization device of FIG. 3 coupled to avascular access device.

FIGS. 8 and 9 are a right-side perspective view and a top view,respectively, of the stabilization device and vascular access device ofFIG. 7 secured to a target location of a patient.

FIG. 10-13 are various views of a stabilization device according to anembodiment.

FIGS. 14 and 15 are a left-side perspective view and a top view,respectively, of the stabilization device of FIGS. 10-13 coupled to avascular access device and positioned at a target location of a patient.

FIG. 16 is a flowchart illustrating a method of using a stabilizationdevice according to an embodiment.

DETAILED DESCRIPTION

In some embodiments, an apparatus includes a stabilization deviceconfigured to stabilize an access device when a distal end portion ofthe access device is inserted through a target location of a patient andat least partially disposed within a portion of the patient. Thestabilization device can include a coupling surface, a proximal surface,and a base surface. The coupling surface is configured to be placed incontact with an adapter coupled to a proximal end portion of the accessdevice. The proximal surface forms at least one angle and is configuredto facilitate securement of the stabilization device to the targetlocation of the patient. The base surface forms a contoured portionconfigured to be placed in contact with the target location and arecessed portion configured to be spaced apart from the target locationwhen the contoured portion is in contact with the target location. Thestabilization device is configured to be secured to the target locationof the patient such that (1) the adapter is retained in a fixed positionrelative to the coupling surface and (2) the access device is stabilizedrelative to the target location.

In some embodiments, an apparatus includes a stabilization deviceconfigured to stabilize a vascular access device at least partiallydisposed within a vein of a patient. The stabilization device includes abase surface and a coupling surface. The base surface forms a contouredportion configured to be placed in contact with a target location of thepatient and a recessed portion configured to be at least partiallyaligned with and spaced apart from the vein of the patient when thecontoured portion is in contact with the target location. The couplingsurface is configured to be placed in contact with an adapter coupled toa proximal end portion of the vascular access device. The couplingsurface includes a first portion and a second portion. The first portionincludes at least one protrusion configured to selectively engage theadapter such that (1) a portion of the adapter is aligned with andconfigured to be placed in contact with the second portion of thecoupling surface when the first portion of the coupling surface is incontact with a distal end portion of the adapter, and (2) the portion ofthe adapter is misaligned with and spaced apart from the second portionof the coupling surface when the first portion of the coupling surfaceis in contact with a proximal end portion of the adapter.

In some embodiments, a method of stabilizing a vascular access device atleast partially disposed within a vein of a patient includes coupling astabilization device to the vascular access device at least partiallydisposed in the vein of the patient. The stabilization device ispositioned on a target location of the patient such that a recessedportion formed by a base surface of the stabilization device is alignedwith the vein. A first strip of medical tape is applied to a proximalsurface of the stabilization device such that each of a first endportion and a second end portion of the first strip of medical tape arein contact with the target location of the patient and are distal to amedial portion of the medical tape. The medial portion of the firststrip of medical tape is at least partially in contact with the proximalsurface of the stabilization device and at least partially in contactwith the target location of the patient. A second strip of medical tapeis applied to a portion of the stabilization device distal to theproximal surface such that the second strip of medical tape partiallyoverlaps at least the first end portion and the second end portion ofthe first strip of medical tape.

In some embodiments, a stabilization device has a proximal end portionand a distal end portion and is configured to be secured to the skin ofa patient. The proximal end portion includes a proximal surface formingat least one angle configured to facilitate securement of thestabilization device to the skin of the patient. A base surface of thestabilization device forms a contour that is configured to be placed incontact with the skin of a patient, and defines a recess along thecontour configured to be spaced apart from the skin of the patient. Thestabilization device is configured to couple to at least one of a hub ofa placed vascular access device or an adapter coupled to the placedvascular access device to stabilize the placed vascular access devicewhen the stabilization device is secured to the skin of the patient.

As used in this specification, the singular forms “a,” “an,” and “the”include plural referents unless the context clearly dictates otherwise.Thus, for example, the term “a member” is intended to mean a singlemember or a combination of members, “a material” is intended to mean oneor more materials or a combination thereof, “a device” is intended tomean a single device or a combination of devices.

As used herein, the terms “about” and “approximately” can be usedinterchangeably and generally mean plus or minus 10% of the valuestated. For example, about 0.5 would include 0.45 and 0.55, about 10would include 9 to 11, about 1000 would include 900 to 1100.

Similarly, the term “substantially” when used in connection with ageometric construction and/or geometric relationship is intended toconvey that the structure and/or relationship so defined is nominallythe recited structure and/or relationship. As one example, a firstportion of a stabilization device that is described as being“substantially perpendicular” to a second portion of the stabilizationdevice is intended to convey that, although a perpendicular relationship(e.g., being arranged, disposed at, and/or otherwise forming a 90° angleor orientation) is desirable, some variance or non-perpendicularity canoccur in a “substantially perpendicular” relationship. As anotherexample, two geometric constructs that are described as beingsubstantially aligned is intended to convey that, although alignment ofthe geometric constructs is desirable, some variance or misalignment canoccur. In some instances, variances such as those described above canresult from, for example, manufacturing tolerances, or other practicalconsiderations. Thus, a geometric construction modified by the term“substantially” includes such geometric properties within a tolerance ofplus or minus 5% of the stated geometric construction. For example, a“substantially perpendicular” relationship is a relationship between twogeometric constructs that is within plus or minus 5% of beingperpendicular.

As used herein, the term “set” can refer to multiple features or asingular feature with multiple parts. For example, when referring to aset of protrusions, the set of protrusions can be considered as oneprotrusion with multiple portions, or the set of protrusions can beconsidered as multiple, distinct protrusions. Thus, a monolithicallyconstructed item can include a set of protrusions. Such a “set” mayinclude multiple portions and/or components that are either continuousor discontinuous from each other. Moreover, a “set” can also be formedfrom multiple components that are produced separately and are laterjoined together (e.g., via a weld, an adhesive, or any suitable method).

The devices and methods described herein are configured to stabilizedevices and/or components of devices that are directly or indirectlyinserted in a patient. Such devices are generally referred to herein asvascular access devices (VADs). Non-limiting examples of a VAD caninclude intravenous (IV) access devices such as peripheral intravenouscatheters (PIV), peripheral intravenous central catheters (PICCs or PIClines), midline catheters, extended dwell catheters (EDCs), etc. Inother embodiments, a VAD can be an intra-arterial access device such asan arterial line, and/or the like. While reference to use with specificaccess devices is made herein, it should be understood that suchreference is presented by way of example and not limitation.

As used herein, the term “catheter” describes an element configured todefine a passageway such as a cannula, a tube, or other lumen-definingstructure. In some instances, a catheter can be used for moving a bodilyfluid from a first location to a second location (e.g., a fluidpassageway to move a bodily fluid out of the body). While cannulas canbe configured to receive a trocar, a guide wire, or an introducer todeliver the cannula to a volume inside the body of a patient, thecatheters and/or cannulas referred to herein need not include or receivea trocar, guide wire, or introducer and can be positioned and/orinserted into, for example, the vasculature of a patient using anysuitable method.

As used in this specification, the term “extension set” generally refersto a device or adapter that is coupled to a hub of a VAD such as aperipheral IV catheter or the like. The “extension sets” can be anysuitable configuration. For example, in some embodiments, an extensionset can be a single port or a multi-port adapter. As a specific example,an extension set can be and/or can refer to a “Y-shaped” dual portextension. In other embodiments, an extension set can be and/or canrefer to a “T-shaped” dual port extension set.

In general, some known extension sets are configured to couple between ahub of a VAD and/or any suitable medical device and can allow one ormore objects, devices, medicaments, fluids, etc. to access a portion ofthe body of a patient (e.g., via the VAD). More particularly, in someinstances, an extension set can be coupled to an indwelling accessdevice (e.g., a PIV or the like) and can facilitate the transfer and/orcollection of one of more fluids. In some instances, the fluid can be abodily fluid including, but not limited to, blood, cerebrospinal fluid,urine, bile, lymph, saliva, synovial fluid, serous fluid, pleural fluid,amniotic fluid, mucus, vitreous, air, and the like, or any combinationthereof.

In some embodiments, any of the extension sets described herein can be acommercially available extension set. That is to say, in someembodiments, and of the stabilization devices described herein can beconfigured for use with a commercially available extension set. In otherembodiments, any of the stabilization devices described herein can beconfigured for use with a custom extension set and/or an extension setconfigured for specific use with the stabilizer devices describedherein. Accordingly, it should be understood, that the term “extensionset” is provided by way of example only and not limitation.

As used in this specification, the words “proximal” and “distal” referto the direction closer to and away from, respectively, a user who wouldplace the device into contact with a patient. Thus, for example, the endof a device first touching the body of the patient would be the distalend, while the opposite end of the device (e.g., the end of the devicebeing manipulated by the user) would be the proximal end of the device.Moreover, the terms “proximal” and “distal” when referring to a positionof a construct or the like can be used to describe, for example, arelative position the construct so described. For example, a firstportion of a device can be said to be in a distal position relative tosecond portion of the device when the position of the first portion ofthe device is further from the user of the device than the position ofthe second portion of the device.

FIGS. 1 and 2 are schematic illustrations of a stabilization device 100according to an embodiment. The stabilization device 100 is configuredto be placed in contact with the skin of a patient at or near aninsertion site of an indwelling or placed vascular access device (VAD)such as those described above. The stabilization device 100 isconfigured to couple to and/or otherwise engage the VAD and/or a devicecoupled to the VAD. Once coupled to the VAD and/or the device coupled tothe VAD, the stabilization device 100 can be secured to the skin of thepatient, which in turn, secures and/or stabilizes at least a portion ofthe VAD relative to the patient, as described in further detail herein.

The stabilization device 100 can be any suitable shape, size, and/orconfiguration. As shown in FIGS. 1 and 2, the stabilization device 100has a proximal end portion 102 and a distal end portion 106, and has abase surface 108 and a coupling surface 112. The proximal end portion102 has a proximal surface 104 that has a predetermined and/or desiredshape. For example, in some embodiments, the proximal surface 104 can beangled, tapered, flared, curved, rounded, and/or the like. As describedin further detail herein, the arrangement and/or shape of the proximalsurface 104 can facilitate the coupling or securing of the stabilizationdevice 100 to the skin of the patient (e.g., via medical tape or thelike).

The base surface 108 can be any suitable shape and/or configuration. Forexample, the base surface 108 can have a contour and/or shape that isgenerally concave. In some embodiments, the concave contour and/or shapecan be based at least in part on a curvature and/or shape of a portionof the patient's anatomy. For example, in some embodiments, the basesurface 108 can have a contour and/or shape that is based at least inpart on a general contour and/or curvature of a patient's hand orforearm (or other suitable IV insertion site). In some embodiments,forming the contour and/or shape of the base surface 108 to be similarto and/or at least partially based on the curvature of an IV insertionsite of the patient can, for example, increase a surface area of thebase surface 108 that is in contact with the skin of the patient, whichin turn, can increase the stability of the stabilization device 100 whensecured to the skin of the patient, as described in further detailherein.

As shown in FIG. 1, the base surface 108 defines a recess 110 (e.g., anotch, indentation, cutout, etc.) that extends along the base surface108 in the direction of a longitudinal axis of the stabilization device100. In other words, the recess 110 extends along the base surface 108in a proximal-distal direction. In some embodiments, the recess 110extends along the base surface 108 through the proximal end portion 102and through the distal end portion 106 (e.g., along the length L of thebase surface 108 (FIG. 2)). In some embodiments, when the base surface108 of the stabilization device 100 is placed in contact with the skinof the patient, the recess 110 can be spaced apart from the skin of thepatient (e.g., not in contact with the skin of the patient). In otherembodiments, the base surface 108 including the recess 110 can be incontact with the skin of the patient.

The stabilization device 100 is configured to be placed in a positionalong the skin of the patient such that the recess 110 is aligned withand/or otherwise disposed over a vein of the patient. In some instances,the stabilization device 100 can be placed on the skin of the patient ator near an insertion site (also referred to as a “target location”) of,for example, an IV catheter. More specifically, the stabilization device100 is configured to be positioned on the skin of the patient such thatthe recess 110 is disposed over the vein in which the VAD (e.g., theindwelling IV catheter, arterial catheter, or the like) is disposed. Insome instances, such an arrangement can reduce an amount of forceexerted by the base surface 108 on the vein, which might otherwiseresult in a reduced flow rate through at least a portion of the vein.For example, in embodiments in which the recess 110 is spaced apart fromthe skin of the patient, the stabilization device 100 does not (orsubstantially does not) exert a force on the vein in which the VAD isdisposed. In other embodiments (e.g., when the recess 110 is in contactwith the skin of the patient), a force exerted on by the recess 110 onthe vein in which the VAD is disposed can be less than a force exertedby other portions of the base surface 108 (e.g., non-recess portions) onor near an area of the patient surrounding the vein.

The coupling surface 112 of the stabilization device 100 can be anysuitable shape, size, and/or configuration. In some embodiments, thecoupling surface 112 can form a contour or shape that is at leastpartially based on a shape of a vascular access device (VAD) 150 (or ahub thereof) and/or a device coupled to a VAD (e.g., an extension set orthe like). In some embodiments, the coupling surface 112 can beconfigured to contact and/or engage an outer surface of the VAD 150 toform and/or define a friction fit therebetween. That is to say, thecoupling surface 112 can have a size and/or shape that is slightlyundersized relative to the VAD 150 to form a friction fit, press fit,interference fit, etc. when the VAD 150 is in contact with the couplingsurface 112.

In some embodiments, the shape and/or contour of the coupling surface112 can be configured to dispose the VAD 150 at a predetermined,predefined, and/or otherwise desired angle relative to the skin of thepatient at or near the insertion site of the VAD 150. For example, insome embodiments, the coupling surface 112 can be angled such that aheight of the coupling surface 112 at or near the proximal end portion102 is greater than a height of the coupling surface 112 at or near thedistal end portion 106. In some embodiments, the coupling surface 112 ofthe stabilization device 100 can be arranged to secure the VAD 150 atany suitable angle based at least in part on an angle of insertion of,for example, the VAD 150 or a catheter thereof. For example, in someembodiments, the coupling surface 112 can be configured to dispose the VAD 150 at an angle that can minimize a risk or likelihood of the VAD 150(e.g., a catheter of the VAD 150) becoming kinked.

As described above, the stabilization device 100 can be used to secure,for example, a device coupled to a vascular access device. By way ofexample, in some embodiments, the stabilization device 100 can beconfigured to couple to and/or secure an IV extension set, which in turnis coupled to an indwelling or placed intravenous catheter. Although notshown in FIGS. 1 and 2, in such embodiments, the coupling surface 112can have a shape and/or contour that is configured and/or suitable foruse with a dual port extension set such as a Y-shaped extension set,T-shaped extension set, and/or the like. For example, in someembodiments, the coupling surface 112 can have a side channel or thelike configured to receive one of the ports of such an extension set(e.g., a side port of a T-shaped extension set). In some embodiments,the side channel or the like can be configured to extend substantiallyperpendicularly relative to the coupling surface 112 and/or the otherportions of the coupling surface 112.

As described above, the stabilization device 100 is configured to secureand/or stabilize the VAD 150 to, for example, the skin of a patient. Forexample, in some instances, an IV catheter (e.g., the VAD 150) can beinserted into the hand of a patient such that (1) a portion of the IVcatheter is disposed within a vein and (2) a hub of the IV catheter isdisposed outside of the patient. In some instances, an extension set(e.g., a T-adapter, Y-adapter, and/or the like) can be coupled to thehub of the IV catheter. With the extension set coupled to the IV hub, auser (e.g., a doctor, nurse, technician, physician, surgeon, and/orother medical professional) can manipulate the stabilization device 100by placing a portion of the extension set (e.g., represented in FIGS. 1and 2 as the VAD 150) in contact with the coupling surface 112 of thestabilization device 100. As described above, the coupling surface 112can be configured to form a friction fit and/or the like with theportion of the extension set to couple the extension set to thestabilization device 100. Although the extension set is described aboveas being coupled to the IV hub prior to being coupled to thestabilization device 100, in other embodiments, the stabilization device100 can be placed in a desired position and/or the extension set can becoupled to the stabilization device 100 prior to coupling the extensionset to the IV hub.

Once the stabilization device 100 is coupled to the extension set, thestabilization device 100 can be positioned on the skin of the patient(e.g., at or near the insertion site). In this example, the IV catheteris inserted into the hand of the patient and thus, the stabilizationdevice 100 is position relative to the hand of the patient. Thus, thebase surface 108 of the stabilization device 100 can be placed incontact with the skin of the patient at or near the insertion site(e.g., the site at which the VAD 150 or IV catheter enters the patient).In some instances, the stabilization device 100 can be adjusted and/orpositioned such that the recess 110 is aligned with and/or otherwisedisposed about or over the vein in which the IV catheter is disposed, asdescribed above.

Having coupled the stabilization device 100 to the extension set andhaving placed the stabilization device 100 in the desired position at ornear the insertion site, the user can secure the stabilization device100 to the patient. In some embodiments, the user can secure thestabilization device 100 via medical tape or the like. For example, auser can remove a strip of medical tape from a roll of medical tape(e.g., a first strip of medical tape) and can apply the strip of medicaltape to the proximal surface 104 of the stabilization device 100 (notshown in FIGS. 1 and 2) such that a first portion of the medical tape isadhered to the proximal surface 104 and a second portion of the medicaltape is adhered to the skin of the patient. In some instances, the usercan substantially center the medical tape relative to the proximalsurface 104. As described above, the proximal surface 104 can have ashape, size, and/or configuration that facilitates the securement of thestabilization device 100. For example, in some embodiments, the proximalsurface 104 can be angled and/or can have a relatively curved contour orthe like such that when the user applies the medical tape to theproximal surface 104, the tape curves, bends, conforms, and/or otherwiseforms a shape and/or follows a path that is at least partially based onthe shape of the proximal surface 104. As described in further detailherein, in some embodiments, the arrangement of the proximal surface 104can be such that end portions of the tape are adhered to the skin of thepatient and positioned distal to the proximal surface 104.

In some instances, the user can remove a second strip of medical tape(not shown in FIGS. 1 and 2) from the roll of medical tape and can applythe second strip of medical tape transversely across a portion of thestabilization device 100 and the VAD 150. In some instances, the usercan apply the second strip of medical tape such that a first end portionof the medical tape is adhered to a portion of the patient's skin on afirst side of the stabilization device 100; a second end portion of themedical tape is adhered to a portion of the patient's skin on a secondside of the stabilization device 100 substantially opposite the firstside of the stabilization device 100; and a medial portion (e.g.,between the first end portion and the second end portion) is adhered toat least one of the stabilization device 100 or the VAD 150. Moreover,the first end portion of the second strip of medical tape can at leastpartially overlap a first end portion of the first strip of medical tapeand the second end portion of the second strip of medical tape can atleast partially overlap a second end portion of the first strip ofmedical tape.

Although the first strip of medical tape and the second strip of tapeare described as being applied in a specific order, it should beunderstood that the strips of medical tape can be applied to thestabilization device 100 and the VAD 150 in any suitable order. Forexample, in some instances, the user can apply the second strip ofmedical tape transversely across the portion of the stabilization device100 and the VAD 150 (as described above) and then can apply the firststrip of medical tape to the proximal surface 104 of the stabilizationdevice 100 (as described above). Thus, in such instances, a portion ofthe first strip of medical tape overlaps a portion of the second stripof medical tape.

Securing the stabilization device 100 to the skin of the patient (e.g.,via the medical tape) results in the stabilization device 100 and/or themedical tape securing, stabilizing, and/or substantially immobilizingthe VAD 150 relative to the patient. That is to say, the arrangement ofthe stabilization device 100 is such that securing the stabilizationdevice 100 and the VAD 150 to the skin of the patient can reduce and/orsubstantially prevent movement of the VAD 150 or at least an IV catheterthereof relative to the vein in which the IV catheter is at leastpartially disposed, as described in further detail herein with respectto a specific embodiment. Moreover, the arrangement of the recess 110along the base surface 108 can reduce and/or can substantially eliminatea force otherwise exerted on the vein in which the VAD 150 (e.g., IVcatheter or the like) is disposed.

FIGS. 3-9 illustrate a stabilization device 200 according to anembodiment. As described above with reference to the stabilizationdevice 100, the stabilization device 200 is configured to be placed incontact with the skin of a patient at or near an insertion site of anindwelling or placed vascular access device (VAD). The stabilizationdevice 200 is configured to couple to and/or otherwise engage the VADand/or a device coupled to the VAD (e.g., an extension set). Oncecoupled to the VAD and/or the device coupled to the VAD, thestabilization device 200 can be secured to the skin of the patient,which in turn, secures and/or stabilizes at least a portion of the VADrelative to the patient, as described in further detail herein.

The stabilization device 200 can be any suitable shape, size, and/orconfiguration. For example, in some embodiments, the stabilizationdevice 200 can have a size and/or shape that is based at least in parton a size and/or shape of the VAD to be stabilized. In some embodiments,the size and/or shape of the stabilization device 200 can facilitateease of use, for example, by simplifying a process of securing thestabilization device 200 to the skin of a patient. In some embodiments,the size and/or shape of the stabilization device 200 can increaseergonomics, grip, and/or the like. For example, in some embodiments, thestabilization device 200 and/or a portion thereof can allow a usermaintain a secure grip on the stabilization device 200 as the usercouples (or decouples) one or more devices to a VAD, an extension set,and/or any other suitable device being stabilized. In some instances,maintaining a secure grip during such a coupling or decoupling processcan limit a force exerted on the stabilization device 200 that mayotherwise be sufficient to move the stabilization device 200 relative toa target location on the patient (e.g., an IV catheter insertion site).In other words, the size and/or shape of the stabilization device 200can allow it to stabilize, secure, and/or substantially immobilize a VADcoupled thereto as the user couples or decouples a device (e.g., a fluidtransfer device or the like) to the VAD.

As shown in FIGS. 3-6, the stabilization device 200 has a proximal endportion 202 and a distal end portion 206, and has a base surface 208 anda coupling surface 212. In general, the coupling surface 212 isconfigured to receive, retain, and/or otherwise couple to an extensionset 260 such as, for example, a T-adapter or T-connector, which in turnis coupled to an indwelling or placed VAD. In this embodiment, theindwelling or placed VAD can be, for example, an IV catheter 250 (seee.g., FIGS. 7-9). The base surface 208 is configured to be placed incontact with the skin of a patient in a predetermined and/or desiredmanner at or near an insertion site of the IV catheter 250 or the like(also referred to herein as a “target location”). Once the stabilizationdevice 200 is coupled to the extension set 260 and the base surface 208is in contact with the skin of the patient at or near the insertionsite, the stabilization device 200 (and the extension set 260) can besecured to the skin of the patient (see e.g., FIGS. 7 and 8) to secureand/or stabilize at least a portion of the IV catheter 250 relative tothe patient and/or the vein in which the IV catheter 250 is disposed, asdescribed in further detail herein.

The proximal end portion 202 has a proximal surface 204 that has apredetermined and/or desired shape. For example, the proximal surface204 can be angled, tapered, flared, curved, rounded, and/or the like. Inthe embodiment shown in FIGS. 3-9, the proximal surface 204 can have arounded, curved, parabolic, and/or substantially bell-shaped perimeter.Moreover, the proximal end portion 202 and/or the proximal surface 204can include a set of extensions 205 (e.g., feet, tabs, pads,protrusions, etc.) that extend transversely away from a center of thestabilization device 200. As described in further detail herein, thearrangement and/or shape of the proximal surface 204 and/or theextensions 205 can facilitate the coupling or securing of thestabilization device 200 to the skin of the patient (e.g., via medicaltape or the like).

The base surface 208 can be any suitable shape and/or configuration. Forexample, as shown in FIGS. 4 and 5, the base surface 208 can have acontour and/or shape that is generally concave. In some embodiments, theconcave contour and/or shape can be based at least in part on acurvature and/or shape of a portion of the patient's anatomy. Forexample, in some embodiments, the base surface 208 can have a contourand/or shape that is based at least in part on a general contour and/orcurvature of a patient's hand or forearm (or other suitable insertionsite and/or target location). In some embodiments, forming the contourand/or shape of the base surface 208 to be similar to and/or at leastpartially based on the curvature of target location of the patient can,for example, increase a surface area of the base surface 208 that is incontact with the skin of the patient, which in turn, can increase thestability of the stabilization device 200 when secured to the skin ofthe patient, as described in further detail herein.

As shown in FIGS. 4 and 5, the base surface 208 defines a recess 210(e.g., a notch, indentation, cutout, etc.) that extends along the basesurface 208 in the direction of a longitudinal centerline of thestabilization device 200. In other words, the recess 210 extends alongthe base surface 208 in a proximal-distal direction. In someembodiments, the recess 210 extends along the base surface 208 throughthe proximal end portion 202 and through the distal end portion 206, asdescribed above with reference to the stabilization device 100 shown inFIG. 2. In some embodiments, the recess 210 can have and/or can form acurved cross-sectional shape with a constant or a variable radius ofcurvature. For example, in some embodiments, the recess 210 can haveand/or can form a parabolic cross-sectional shape. In other embodiments,the recess 210 can have and/or can form any suitable cross-sectionalshape such as, for example, a V-shape, a U-shape, a W-shape, and/or anyother suitable cross-sectional shape. In some embodiments, the sizeand/or shape of the recess 210 can be substantially constant along alength of the stabilization device 200. In other embodiments, the sizeand/or shape of the recess 210 can vary along the length of thestabilization device 200. For example, in some embodiments, the recess210 can be tapered, decreasing in size and/or shape from a first size atthe proximal end portion 202 to a second size at the distal end portion206 (or vice versa).

The stabilization device 200 is configured to be placed in a positionalong the skin of the patient such that the recess 210 is aligned withand/or otherwise disposed over the vein in which the IV catheter 250 isdisposed. In some embodiments, when the base surface 208 of thestabilization device 200 is placed in contact with the skin of thepatient, the recess 210 can be spaced apart from the skin of the patient(e.g., not in contact with the skin of the patient). In otherembodiments, the base surface 208 including the recess 210 can be incontact with a portion of the skin of the patient. In some embodiments,the recess 210 can have a height (or depth) and a width that are eachlarger than a diameter of the vein in which the IV catheter 250 is to bedisposed. In other words, a size and/or shape of the recess 210 can bebased at least in part on a size and/or shape of a vein over which thestabilization device 200 is disposed. For example, in some embodiments,the recess 210 can have a height or depth that is approximately 0.5millimeters (mm) to approximately 3.0 mm and a width that isapproximately 5.0 mm to approximately 40.0 mm. As one example, a recess210 can have a height or depth that is approximately 2.0 mm and a widththat is approximately 20 mm.

While the recess 210 is particularly shown in, for example, FIGS. 4 and5, in some embodiments, the recess 210 can have any suitable size and/orshape. In some embodiments, the size and/or shape of the recess 210 canaccount for variations in vein size, shape, and/or path. For example, insome instances, a vein in which the IV catheter 250 is disposed can haveone or more branch vessels coupled thereto, can extend in a non-linearor curved path, can extend at an angle, and/or otherwise can vary insize, shape, and/or arrangement between patients. As such, the recess210 can have a width that is sufficiently large to allow the recess 210to be disposed over a vein that can vary in size, shape, and/orarrangement. In some embodiments, for example, the recess 210 can have awidth that is slightly smaller than a width of the base surface 208. Insuch embodiments, a relatively thin portion of the base surface 208 canbe disposed on opposite sides of the recess 210. In other embodiments,the base surface 208 can include two parallel or substantially parallelprotrusions, bumps, ridges, rails, etc. that that collectively define aspace therebetween. In such embodiments, the portion of the base surface208 disposed between the two protrusions or the like can form and/or canfunction similar to the recess 210.

In some embodiments, forming and/or defining the recess 210 to be larger(e.g., in height and/or width) than the vein in which the IV catheter250 is disposed can, for example, reduce an amount of force that wouldotherwise be exerted by the base surface 208 on the vein. In someinstances, such a force exerted by the base surface 208 on the vein maybe sufficient to reduce a flow of blood within the vein. In somespecific instances, such a reduction in flow may negatively impact theability to withdraw blood from the vein and/or may impede the deliveryof fluids into the vein. Accordingly, forming the recess 210 in the basesurface 208 is such that the stabilization device 200 does not (orsubstantially does not) exert a force on the vein in which the IVcatheter 250 is disposed, thereby allowing the stabilization device 200to secure and stabilize the IV catheter 250 without substantiallyimpeding a flow of fluid through the vein.

While the recess 210 is described above as being configured to reduceand/or substantially remove a force exerted on the vein in which the IVcatheter 250 is disposed, in some embodiments, the recess 210 can allowfor movement and/or reconfiguration of a portion of the patient whilecontinuing to provide stabilization to or for the IV catheter 250. Forexample, in some embodiments, an IV catheter (e.g., the IV catheter 250)can be inserted into a patient's cephalic or basilic vein and astabilization device 200 (e.g., the stabilization device 200) can besecured to the patient's antecubital fossa region. In some instances,bending of the patient's arm (e.g., at the elbow) can result in a changein tension, stress, and/or strain of the skin both in a circumferentialdirection and an axial direction along the patient's arm. In someinstances, such a change in tension or the like can result in a bunchingor bulging of skin at or near the antecubital fossa region. In someinstances, such a bunching or bulging of skin can result in undesiredlifting or movement of a stabilization device relative to an IVinsertion site, which in turn, can result in undesired movement,bending, kinking, etc. of the IV catheter disposed in the vein.

In some embodiments, however, the arrangement of the recess 210 of thestabilization device 200 can allow at least a portion of the skin tobunch or bulge in a space defined by the recess 210, thereby at leastpartially filling the void of the recess 210 and reducing and/orsubstantially preventing undesired lifting or movement of thestabilization device 200. In other words, in some instances, thearrangement of the stabilization device 200 can be such that thestabilization device 200 stabilizes, secures, and/or substantiallyimmobilizes the IV catheter 250 despite at least some movement of thepatient. Moreover, in some embodiments, the recess 210 can extend alongthe width of the stabilization device 200 such that only the edges ofthe base surface 208 and/or only protrusions extending from the basesurface 208 are in contact with the skin. In such embodiments, thisarrangement can allow the skin to shift and stretch axially underneathand to either side of the stabilization device 200 as shear forces areapplied by movement of the skin, thereby reducing the amount of forcethat can otherwise result in lateral movement of the stabilizationdevice 200 relative to the insertion site and/or target location.

The coupling surface 212 of the stabilization device 200 can be anysuitable shape, size, and/or configuration. In the embodiment shown inFIGS. 3-9, the coupling surface 212 can form a contour or shape that isat least partially based on a shape of the extension set 260. In someembodiments, the coupling surface 212 can be configured to contactand/or engage an outer surface of the extension set 260 to form and/ordefine a friction fit therebetween. That is to say, the coupling surface212 can have a size and/or shape that is slightly undersized relative tothe extension set 260 to form a friction fit, press fit, interferencefit, etc. when the extension set 260 is in contact with the couplingsurface 212.

In the embodiment shown in FIGS. 3-9, the coupling surface 212 can beconfigured to receive and/or couple to a T-shaped adapter or connector(e.g., the extension set 260). For example, the coupling surface 212includes a distal notch 214 and one or more side channels 216. Thedistal notch 214 formed by and/or along the coupling surface 212 can beconfigured to accommodate a distal locking mechanism 262 (e.g., a LuerLok®) of the extension set 260. For example, in some embodiments, theextension set 260 (e.g., the T-adapter) can include a rotatable lock ata distal end portion thereof that is configured to physically andfluidically couple the extension set 260 to the IV catheter 250.Accordingly, the distal notch 214 can provide sufficient space for auser to grasp and rotate the rotatable lock to couple or decouple thedistal locking mechanism 262 of the extension set 260 to or from the IVcatheter 250. Moreover, the extension set 260 can couple to the couplingsurface 212 such that a proximal locking mechanism 261 of the extensionset 260 is proximal to the proximal surface 204 of the stabilizationdevice 200, as shown in FIG. 7. In some embodiments, such an arrangementcan facilitate the coupling or decoupling of one or more devices (e.g.,a fluid transfer device, syringe, fluid reservoir, etc.) to or from theproximal locking mechanism 261 of the extension set 260.

The one or more side channels 216 of the stabilization device 200 can beany suitable shape, size, and/or configuration. In the embodiment shownin FIGS. 3-9, the stabilization device 200 includes two side channels216, with one side channel 216 on opposite sides of the stabilizationdevice 200 and extending in a perpendicular and/or transverse directionrelative to, for example, a longitudinal centerline C of thestabilization device 200 (see e.g., FIG. 6). At least one of the sidechannels 216 is configured to receive a side port 263 of the extensionset 260 (see e.g., FIG. 7). For example, in the embodiment shown inFIGS. 3-9, the extension set 260 is a dual port extension set having a“T” configuration in which the side port 263 is substantiallyperpendicular to a longitudinal axis A defined between the proximallocking mechanism 261 and the distal locking mechanism 262 (see e.g.,FIG. 7). Accordingly, when the extension set 260 is coupled to thecoupling surface 212, the longitudinal centerline C of the stabilizationdevice 200 and the longitudinal axis A defined by the extension set 260are aligned and/or substantially coaxial and the side port 263 of theextension set 260 can be placed in contact with, disposed in, and/orextend through the side channel 216 on a left side of the stabilizationdevice 200 or on a right side of the stabilization device 200.

In some embodiments, the arrangement of the coupling surface 212 and theextension set 260 can be such that the extension set 260 is placed incontact with the coupling surface 212 and rotated into a position inwhich the side port 263 is disposed in one of the side channels 216. Insome embodiments, a portion of the coupling surface 212 that formsand/or defines the side channels 212 can form a snap or press fit withat least a portion of the side port 263 of the extension set 260.Moreover, in use, the side port 263 of the extension set 260 istypically coupled to a flexible tubing 265 (see e.g., FIG. 7) or thelike and, as such, the side channels 216 can be configured to allow thecoupling of the flexible tubing 265 to the side port 263 of theextension set 260 without resulting in undue bending or kinking of theflexible tubing 265.

In some embodiments, the shape and/or contour of the coupling surface212 can be configured to place and/or maintain a VAD (e.g., the IVcatheter 250) at a predetermined, predefined, and/or otherwise desiredangle relative to the skin of the patient at or near the insertion siteof the IV catheter 250 (or target location). For example, in someembodiments, the coupling surface 212 can be angled such that a heightof the coupling surface 212 at or near the proximal end portion 202 isgreater than a height of the coupling surface 212 at or near the distalend portion 206. In some embodiments, the coupling surface 212 can beconfigured to receive, couple to, and/or secure the IV catheter 250 atan angle between, for example, about 3° and about 15° relative to theskin of the patient at the insertion site. Specifically, in someembodiments, the coupling surface 212 can be configured to receive,couple to, and/or secure the IV catheter 250 at an angle of about 10°,about 8°, about 6°, or less. In some embodiments, the coupling surface212 of the stabilization device 200 can be arranged to secure the IVcatheter 250 at any suitable angle based at least in part on an angle ofinsertion of, for example, the IV catheter. For example, in someembodiments, the coupling surface 212 can be configured to place and/ormaintain the IV catheter 250 at an angle that can minimize a risk orlikelihood of the IV catheter 250 becoming kinked (e.g., at the IVcatheter insertion site or skin entry).

In some embodiments, the stabilization device 200 can be configured tosecure the IV catheter 250 at an angle that is based at least in part onan IV insertion site. For example, in some embodiments, a stabilizationdevice can be configured to secure an IV catheter at a first angle whenthe IV catheter is inserted into, for example, the antecubital fossa anda second angle, different from the first angle, when the IV catheter isinserted into, for example, the hand. In such embodiments, thestabilization device 200 can include an indicator and/or can have acolor or the like configured provide an indication to a user associatedwith the intended use or intended insertion site.

As shown in FIGS. 7-9, the stabilization device 200 is configured tosecure and/or stabilize the IV catheter 250 relative to, for example, atarget location of a patient. For example, in some instances, the IVcatheter 250 can be inserted into the hand of a patient (e.g., at oralong a target location) such that (1) a portion of the IV catheter 250is disposed within a vein (insertion of the IV catheter 250 is not shownin FIGS. 7-9) and (2) a hub of the IV catheter 250 is disposed outsideof the patient. In some instances, the extension set 260 (e.g., theT-adapter) can be physically and fluidically coupled to the hub of theIV catheter 250.

With the extension set 260 coupled to the IV hub, a user (e.g., adoctor, nurse, technician, physician, surgeon, and/or other medicalprofessional) can manipulate the stabilization device 200 by placing aportion of the extension set 260 in contact with the coupling surface212 of the stabilization device 200. As described above, the couplingsurface 212 can be configured to form a friction fit and/or the likewith the portion of the extension set 260 to couple the extension set260 to the stabilization device 200. As shown, for example, in FIG. 7,the extension set 260 can be coupled to the coupling surface 212 of thestabilization device 200 such that the distal locking mechanism 262 orthe like of the extension set 260 is at least partially disposed inand/or otherwise aligned with the distal notch 214. As described above,such an arrangement can allow the user to engage the distal lockingmechanism 262 to couple the extension set 260 to or decouple theextension set 260 from the IV catheter 250. In addition, the side port263 of the extension set 260 is positioned within one of the sidechannels 216 (see e.g., FIG. 7) such that the flexible tubing 265coupled to the side port 263 can extend out of the side channel 216.Accordingly, the side port 263 of the extension set 260 can be used todeliver fluid to or withdraw fluid from the vein in which the IVcatheter 250 is disposed. Furthermore, the proximal port or lockingmechanism 261 of the extension set 260 can be disposed in a proximalposition relative to the proximal surface 204 when the extension set 260is coupled to the coupling surface 212. In this manner, any suitabledevice can couple to the proximal port or locking mechanism 261 todeliver fluids to, withdraw fluids from, and/or otherwise gain access tothe vein in which the IV catheter 250 is disposed.

Once the stabilization device 200 is coupled to the extension set 260,the stabilization device 200 can be positioned on the skin of thepatient (e.g., at or near the insertion site or target location). Inthis example, the IV catheter 250 is inserted into the hand of thepatient and thus, the stabilization device 200 is positioned relative tothe hand of the patient. Thus, the base surface 208 of the stabilizationdevice 200 can be placed in contact with the skin of the patient at ornear the insertion site of the IV catheter 250 and/or otherwise at ornear a target location of the patient. As described above, thestabilization device 200 can be adjusted and/or positioned such that therecess 210 is aligned with and/or otherwise disposed about or over thevein in which the IV catheter 250 is disposed. In this manner, securingthe stabilization device 200 to the skin of the patient does not resultin the base surface 208 exerting a force on the vein that may otherwisebe sufficient to occlude and/or restrict flow through the vein.

Having coupled the stabilization device 200 to the extension set 260 andhaving placed the stabilization device 200 in the desired position at ornear the insertion site (e.g., such that the recess 210 is aligned withor disposed over the vein in which the IV catheter 250 is disposed), theuser can secure the stabilization device 200 to the patient. In someembodiments, the user can secure the stabilization device 200 viamedical tape or the like, as shown, for example, in FIGS. 8 and 9. Moreparticularly, in some instances, a user can remove a first strip ofmedical tape 232 from a roll of medical tape and can apply the firststrip of medical tape 232 to the proximal surface 204 of thestabilization device 200 such that a first portion of the medical tapeis adhered to the proximal surface 204 and a second portion of themedical tape is adhered to the skin of the patient. For example, in someinstances, the user can place the first strip of the medical tape 232such that a first portion of the width of the first strip 232 overlaysand/or is adhered to the proximal surface 204 of the stabilizationdevice 200 while a second portion of the width of the first strip 232overlays and/or is adhered to the skin of the patient, as shown in FIGS.8 and 9.

As described above, the proximal surface 204 can have a shape, size,and/or configuration that facilitates the securement of thestabilization device 200. For example, in some embodiments, the proximalsurface 204 can be angled and/or can have a relatively curved contour orthe like such that when the user applies the first strip of medical tape232 to the proximal surface 204, the tape curves bends, conforms, and/orotherwise forms a shape and/or follows a path that is at least partiallybased on the shape of the proximal surface 204. As shown in FIGS. 8 and9, the shape and/or configuration of the proximal surface 204 is suchthat a portion of the first strip of medical tape overlays and/or isadhered to the extensions 205. Moreover, the arrangement of the proximalsurface 204 and/or the extensions 205 is such that the first strip ofmedical tape 232 curves and/or bends such that end portions of the firststrip 232 are adhered to the skin of the patient and positioned distalto, for example, a medial or middle portion of the first strip 232, asindicated by the arrows AA in FIGS. 8 and 9.

After securing the first strip of medical tape 232, the user can removea second strip of medical tape 234 from the roll of medical tape and canapply the second strip of medical tape 234 transversely across a portionof the stabilization device 200 and the IV catheter 250, as indicated bythe arrows BB in FIGS. 8 and 9. As shown, the user can apply the secondstrip of medical tape 234 such that a first end portion of the secondstrip of medical tape 234 is adhered to a portion of the patient's skinon a first side of the stabilization device 200; a second end portion ofthe second strip of medical tape 234 is adhered to a portion of thepatient's skin on a second side of the stabilization device 200substantially opposite the first side of the stabilization device 200;and a medial or middle portion (e.g., between the first end portion andthe second end portion) is adhered to at least one of the stabilizationdevice 200 or the IV catheter 250. Moreover, the first end portion ofthe second strip of medical tape 234 can at least partially overlap afirst end portion of the first strip of medical tape 232 and the secondend portion of the second strip of medical tape 234 can at leastpartially overlap a second end portion of the first strip of medicaltape 232, as shown in FIGS. 8 and 9. In some embodiments, positioning aportion of the second strip of medical tape 234 over a portion of thefirst strip of medical tape 232 can enhance the adhesion of at least oneof the first strip 232 or the second strip 234. In other words,positioning a portion of the second strip of medical tape 234 over aportion of the first strip of medical tape 232 can reduce a likelihoodof the portion of the first strip of medical tape 232 from workingloose, decoupling, and/or otherwise breaking the adhesive bond.

As described above, securing the stabilization device 200 to the skin ofthe patient (e.g., via the strips of medical tape 232 and 234) resultsin the stabilization device 200 and/or the medical tape securing,stabilizing, and/or substantially immobilizing the IV catheter 250relative to the patient. That is to say, the arrangement of thestabilization device 200 is such that securing the stabilization device200 and the IV catheter 250 to the skin of the patient can reduce and/orsubstantially prevent movement of the IV catheter 250 or at least an IVcatheter thereof relative to the vein in which the IV catheter is atleast partially disposed, as described in further detail herein withrespect to a specific embodiment. Moreover, the arrangement of therecess 210 along the base surface 208 is such that securing and/oradhering the stabilization device 200 to the skin of the patient doesnot exert a force on the vein in which the IV catheter 250 is disposed,thereby reducing and/or substantially eliminating any obstruction and/orrestriction otherwise resulting from such a force.

While the stabilization device 200 is described above with reference toFIGS. 7-9 as being secured to the skin of a patient via, for example,two strips of medical tape, it should be understood that thestabilization device 200 can be secured to the skin of the patient inany suitable manner. For example, although not shown, in someembodiments, the stabilization device 200 can be secured to the skin viaa transparent dressing or the like such as, for example, Tegaderm™and/or the like. In such instances, the transparent dressing can includean adhesive or the like disposed around the perimeter of the dressing oralong one or more edges of the dressing. In some embodiments, thetransparent dressing can be sized and/or shaped for use with thestabilization device 200. For example, the transparent dressing can havea size or shape that allows the dressing to cover at least the IVinsertion site while allowing access to, for example, a proximal port ofthe extension set 260 or the IV catheter 250 (e.g., similar to themedical tape shown in FIGS. 8 and 9). In some instances, multiplemethods of securing the stabilization device 200 to the skin can be usedsuch as, for example, a combination of transparent dressing and medicaltape, and/or any other suitable method of securement (such as anadhesive or the like).

FIGS. 10-15 illustrate a stabilization device 300 according to anembodiment. As described above with reference to the stabilizationdevices 100 and/or 200, the stabilization device 300 is configured to beplaced in contact with the skin of a patient at or near an insertionsite of an indwelling or placed vascular access device (VAD). Thestabilization device 300 is configured to couple to and/or otherwiseengage the VAD and/or a device or adapter coupled to the VAD (e.g., anextension set). Once coupled to the VAD and/or the device or adaptercoupled to the VAD, the stabilization device 300 can be secured to theskin of the patient, which in turn, secures and/or stabilizes at least aportion of the VAD relative to the patient, as described in furtherdetail herein.

The stabilization device 300 can be any suitable shape, size, and/orconfiguration. For example, in some embodiments, the stabilizationdevice 300 can have a size and/or shape that is based at least in parton a size and/or shape of the VAD to be stabilized. In some embodiments,the size and/or shape of the stabilization device 300 can facilitateease of use, for example, by simplifying a process of securing thestabilization device 300 to the VAD, the device or adapter coupled tothe VAD, and/or the skin of a patient. In some embodiments, the sizeand/or shape of the stabilization device 300 can increase ergonomics,grip, and/or the like. For example, in some embodiments, thestabilization device 300 and/or a portion thereof can allow a usermaintain a secure grip on the stabilization device 300 as the usercouples (or decouples) one or more devices to a VAD, an extension set,and/or any other suitable device being stabilized, as described abovewith reference to the stabilization device 200. In some embodiments,aspects and/or portions of the stabilization device 300 can besubstantially similar to corresponding aspects and/or portions of thestabilization device 200. Accordingly, such aspects and/or portions ofthe stabilization device 300 are not described in further detail herein.

As shown in FIGS. 10-13, the stabilization device 300 has a proximal endportion 302 and a distal end portion 306, and has a base surface 308 anda coupling surface 312. In general, the coupling surface 312 isconfigured to receive, retain, and/or otherwise couple to an extensionset 360 such as, for example, a T-adapter or T-connector, which in turnis coupled to an indwelling or placed VAD, as described above withreference to the coupling surface 212 of the stabilization device 200.In this embodiment, the indwelling or placed VAD can be, for example, anIV catheter 350 (see e.g., FIGS. 14 and 15). The base surface 308 isconfigured to be placed in contact with the skin of a patient in apredetermined and/or desired manner at or near an insertion site of theIV catheter 350 or the like (also referred to herein as a “targetlocation”). Once the stabilization device 300 is coupled to theextension set 360 and the base surface 308 is in contact with the skinof the patient at or near the insertion site, the stabilization device300 (and the extension set 360) can be secured to the skin of thepatient to secure and/or stabilize at least a portion of the IV catheter350 relative to the patient and/or the vein in which the IV catheter 350is disposed, as described above with reference to the stabilizationdevice 200.

The proximal end portion 302 has a proximal surface 304 that has apredetermined and/or desired shape. For example, the proximal surface304 can be angled, tapered, flared, curved, rounded, and/or the like(see e.g., FIGS. 10-12). In some embodiments, the proximal surface 304can have a rounded, curved, parabolic, and/or substantially bell-shapedperimeter (see e.g., FIG. 13). Moreover, the proximal end portion 302and/or the proximal surface 304 can include a set of extensions 305(e.g., feet, tabs, pads, protrusions, etc.) that extend transverselyaway from a center of the stabilization device 300. In some embodiments,the arrangement and/or shape of the proximal surface 304 and/or theextensions 305 can facilitate the coupling or securing of thestabilization device 300 to the skin of the patient (e.g., via medicaltape or the like), as described in detail above with reference to thestabilization device 200.

The base surface 308 can be any suitable shape and/or configuration. Forexample, as shown in FIGS. 12 and 13, the base surface 308 can have acontour and/or shape that is generally concave. In some embodiments, theconcave contour and/or shape can be based at least in part on acurvature and/or shape of a portion of the patient's anatomy. Forexample, in some embodiments, the base surface 308 can have a contourand/or shape that is based at least in part on a general contour and/orcurvature of a target location and/or IV insertion site of a patient.For example, as described above with reference to the base surface 208of the stabilization device 200, in some embodiments, the contour and/orcurvature can be based on a shape and/or curve of a patient's hand orforearm (or other suitable insertion site and/or target location).

As shown in FIG. 13, the base surface 308 defines a recess 310 (e.g., anotch, indentation, cutout, etc.) that extends along the base surface308 in the direction of a longitudinal centerline of the stabilizationdevice 300. In other words, the recess 310 extends along the basesurface 308 in a proximal-distal direction. In some embodiments, therecess 310 extends along the base surface 308 through the proximal endportion 302 and through the distal end portion 306, as described abovewith reference to the stabilization devices 100 and/or 200. In someembodiments, the base surface 308 and the recess 310 can be similar toand/or substantially the same as the base surface 208 and the recess210, respectively, of the stabilization device 200. Accordingly, thesize, shape, configuration, and/or form of the base surface 308 and/orthe recess 310 are not described in further detail herein.

As described above with reference to the stabilization device 200, thestabilization device 300 is configured to be placed in a position at oron a target location (e.g., along the skin of the patient at or near anIV insertion site) such that the recess 310 is aligned with and/orotherwise disposed over the vein in which the IV catheter 350 isdisposed. In some embodiments, when the base surface 308 of thestabilization device 300 is placed in contact with the skin of thepatient, the recess 310 can be spaced apart from the skin of the patient(e.g., not in contact with the skin of the patient). In someembodiments, the recess 310 can have a height (or depth) and a widththat are each larger than a diameter of the vein in which the IVcatheter 350 is to be disposed. In other words, a size and/or shape ofthe recess 310 can be based at least in part on a size and/or shape of avein over which the stabilization device 300 is disposed. As such, therecess 310 can have a height and/or width that is sufficiently large toallow the recess 310 to be disposed over and/or above or about a veinthat can vary in size, shape, and/or arrangement. Moreover, formingand/or defining the recess 310 to be larger (e.g., in height and/orwidth) than the vein in which the IV catheter 350 is disposed can, forexample, reduce an amount of force that would otherwise be exerted bythe base surface 308 on the vein and/or can allow for movement and/orreconfiguration of a portion of the patient while continuing to providestabilization to or for the IV catheter 350, as described in detailabove with reference to the stabilization device 200.

The coupling surface 312 of the stabilization device 300 can be anysuitable shape, size, and/or configuration. In the embodiment shown inFIGS. 10-15, the coupling surface 312 can form a contour or shape thatis at least partially based on a shape of the extension set 360. In someembodiments, the coupling surface 312 can be configured to contactand/or engage an outer surface of the extension set 360 to form and/ordefine a friction fit therebetween. That is to say, at least a portionof the coupling surface 312 can have a size and/or shape that isslightly undersized relative to a corresponding portion of the extensionset 360 to form a friction fit, press fit, interference fit, etc. whenthe extension set 360 is in contact with the coupling surface 312.

In some embodiments, the coupling surface 312 can be configured toreceive and/or couple to a T-shaped adapter or connector (e.g., theextension set 360), which in turn is coupled to a VAD (e.g., the IVcatheter 350). As such, the stabilization device 300 can be configuredto stabilize, support, and/or secure the VAD or IV catheter 350 when thecoupling surface 312 is placed in contact with the T-shaped adapter,connector, and/or extension set 360. In some embodiments, the shapeand/or contour of the coupling surface 312 can be configured to placeand/or maintain a VAD (e.g., the IV catheter 350) at a predetermined,predefined, and/or otherwise desired angle relative to the skin of thepatient at or near the insertion site of the IV catheter 350 (or targetlocation). For example, in some embodiments, the coupling surface 312can be angled such that a height of the coupling surface 312 at or nearthe proximal end portion 302 is greater than a height of the couplingsurface 312 at or near the distal end portion 306. In some embodiments,the coupling surface 312 can be configured to receive, couple to, and/orsecure the IV catheter 350 at an angle between, for example, about 3°and about 15° relative to the skin of the patient at or near theinsertion site. In some embodiments, the coupling surface 312 of thestabilization device 300 can be arranged to secure the IV catheter 350at any suitable angle based at least in part on an angle of insertionof, for example, the IV catheter 350 and/or the insertion site of thepatient, as described in detail above with reference to thestabilization device 200.

As shown, for example, in FIG. 12, the coupling surface 312 includes adistal notch 314, one or more side channels 316, and one or moreprotrusions 318. The distal notch 314 formed by and/or along thecoupling surface 312 can be configured to accommodate a distal lockingmechanism 362 (e.g., a Luer Lok®) of the extension set 360. For example,in some embodiments, the extension set 360 (e.g., the T-adapter) caninclude a rotatable lock at a distal end portion thereof that isconfigured to physically and fluidically couple the extension set 360 tothe IV catheter 350. Accordingly, the distal notch 314 can providesufficient space for a user to grasp and rotate the rotatable lock tocouple or decouple the distal locking mechanism 362 of the extension set360 to or from the IV catheter 350, as described above with reference tothe coupling surface 212 of the stabilizing device 200.

The one or more side channels 316 of the stabilization device 300 can beany suitable shape, size, and/or configuration. In the embodiment shownin FIGS. 10-15, the stabilization device 300 includes two side channels316, with one side channel 316 on opposite sides of the stabilizationdevice 300 and extending in a perpendicular and/or transverse directionrelative to, for example, a longitudinal centerline C of thestabilization device 300 (see e.g., FIG. 12). At least one of the sidechannels 316 is configured to receive a side port 363 of the extensionset 360. For example, as shown in FIGS. 14 and 15, the extension set 360can be a dual port extension set having a “T” configuration in which theside port 363 is substantially perpendicular to a longitudinal axis Adefined between the proximal locking mechanism 361 and the distallocking mechanism 362 (see e.g., FIG. 15). Accordingly, when theextension set 360 is coupled to the coupling surface 312, thelongitudinal centerline C of the stabilization device 300 and thelongitudinal axis A defined by the extension set 360 are aligned and/orsubstantially coaxial and the side port 363 of the extension set 360 canbe placed in contact with, disposed in, and/or extend through the sidechannel 316 on a left side of the stabilization device 300 or on a rightside of the stabilization device 300.

In some embodiments, the arrangement of the coupling surface 312 and theextension set 360 can be such that the extension set 360 is placed incontact with the coupling surface 312 and rotated into a position inwhich the side port 363 is disposed in one of the side channels 316. Insome embodiments, a portion of the coupling surface 312 that formsand/or defines the side channels 312 can form a snap or press fit withat least a portion of the side port 363 of the extension set 360.Moreover, in use, the side port 363 of the extension set 360 istypically coupled to a flexible tubing 365 (see e.g., FIGS. 14 and 15)or the like and, as such, the side channels 316 can be configured toallow the coupling of the flexible tubing 365 to the side port 363 ofthe extension set 360 without resulting in undue bending or kinking ofthe flexible tubing 365.

In some embodiments, the one or more protrusions 318 of the couplingsurface 312 can be arranged and/or configured to ensure thestabilization device 300 is in a desired orientation and/or is facing adesired direction when the coupling surface 312 is placed in contactwith the extension set 360. For example, as shown in FIG. 12, thecoupling surface 312 can include a set of protrusions 318 that extendfrom a portion of the coupling surface 312 that is distal to the sidechannels 316. The set of protrusions 318 can be any suitableconfiguration and/or arrangement. For example, while the couplingsurface 312 is shown as including a set of three protrusions 318, inother embodiments, the coupling surface 312 can include any number ofprotrusions 318 (e.g., one protrusion, two protrusions, fourprotrusions, five protrusions, or more). In some embodiments, theprotrusions 318 can be substantially uniform or can have one or moredifferent heights, widths, lengths, etc.

In some embodiments, the protrusions 318 can be configured toselectively engage a portion of the extension set 360 such that thecoupling surface 312 is placed in a desired position and/or orientationrelative to the extension set 360. For example, in some embodiments, thearrangement of the protrusions 318 can be such that when the distal endportion 306 of the stabilization device 300 is aligned with or placed incontact with the distal locking mechanism 362, the side port 363 of theextension set 360 is aligned with the side channels 316. Morespecifically, when the coupling surface 312 is placed in contact withthe extension set 360 such that a portion of the distal lockingmechanism 362 is disposed in and/or aligned with the distal notch 314defined by the coupling surface 312, the side port 363 of the extensionset 360 is aligned with and capable of being disposed in one of the sidechannels 316, as shown in FIGS. 14 and 15. In other words, when thedistal end portion 306 of the stabilization device 300 and the distallocking mechanism 362 are placed in the same orientation (e.g., when thestabilization device 300 and the extension set 360 are facing the samedirection), the side port 363 of the extension set 360 can be positionedin one of the side channels 316. Said yet another way, when the distallocking mechanism 362 is disposed in and/or aligned with the distalnotch 314 defined by the coupling surface 312, a position of the sideport 363 along the longitudinal axis A of the extension set 360 issubstantially aligned with a position of the side channels 316 along thelongitudinal centerline C of the stabilization device 300, therebyallowing the side port 363 to be disposed in one of the side channels316.

As described above, the arrangement of the protrusions 318 can allowand/or can be configured to allow the coupling surface 312 to be placedin contact with and/or coupled to the extension set 360 when thestabilization device 300 is in a desired orientation relative to theextension set. Conversely, the arrangement of the protrusions 318 can besuch that if the stabilization device 300 is placed in an undesiredorientation relative to the extension set 360, the contact between thecoupling surface 312 and the extension set 360 can be limited and/or acoupling therebetween can be limited and/or prevented. For example, ininstances in which the distal end portion 306 of the stabilizationdevice 300 and the distal locking mechanism 362 are not aligned theprotrusions 318 can selectively engage a portion of the extension set360, which in turn, results in the side port 363 of the extension set360 being misaligned relative to the side channels 316.

In some embodiments, the misalignment between the side port 363 and theside channels 316 can limit and/or substantially prevent the couplingsurface 312 from being placed in contact with and/or being coupled tothe extension set 360, which can provide an indication to a user thatthe stabilization device 300 is in an undesirable orientation relativeto the extension set 360 (and/or vice versa). For example, in someinstances, the protrusions 318 can selectively engage a portion of theextension set 360 to misalign the side port 363 relative to the sidechannels 316 when the stabilization device 300 and the extension set 360are placed in opposite directions and/or orientations. Moreparticularly, the protrusions 318 can selectively engage a portion ofthe extension set 360 to misalign the side port 363 relative to the sidechannels 316 when the coupling surface 312 of the stabilization device300 is at least partially placed in contact with the extension set 360such that the proximal locking mechanism 361 of the extension set 360 isaligned with and/or at least partially disposed in the distal notch 314defined by the coupling surface 312. Said another way, when the proximallocking mechanism 361 of the extension set 360 is disposed in and/oraligned with the distal notch 314 defined by the coupling surface 312, aposition of the side port 363 along the longitudinal axis A of theextension set 360 is misaligned relative to a position of the sidechannels 316 along the longitudinal centerline C of the stabilizationdevice 300, which in turn, can limit and/or substantially prevent theside port 363 from being disposed in one of the side channels 316. Putsimply, in some embodiments, the protrusions 318 can limit and/orsubstantially prevent the stabilization device 300 from being placed ina desired contact with or coupled to the extension set 360 while thestabilization device 300 is in a backwards orientation relative to theextension set 360.

As described above with reference to the stabilization device 200, thestabilization device 300 is configured to secure and/or stabilize the IVcatheter 350 relative to, for example, a target location of a patient.For example, in some instances, the IV catheter 350 can be inserted intothe hand of a patient (e.g., at or along a target location) such that(1) a portion of the IV catheter 350 is disposed within a vein and (2) ahub of the IV catheter 350 is disposed outside of the patient. In someinstances, the extension set 360 (e.g., the T-adapter) can be physicallyand fluidically coupled to the hub of the IV catheter 350.

With the extension set 360 coupled to the IV hub, a user (e.g., adoctor, nurse, technician, physician, surgeon, and/or other medicalprofessional) can manipulate the stabilization device 300 by placing aportion of the extension set 360 in contact with the coupling surface312 of the stabilization device 300. As described above, the couplingsurface 312 can be configured to form a friction fit and/or the likewith the portion of the extension set 360 to couple the extension set360 to the stabilization device 300. Moreover, the arrangement of theprotrusions 318 can be configured to selectively engage the extensionset 360 such that a user can visually inspect whether the stabilizationdevice 300 and the extension set 360 are placed in a desired orientationrelative each other, as described in detail above. Accordingly, thestabilization device 300 can be placed in contact with and/or coupled tothe extension set 360 as described in detail above and shown in, forexample, FIGS. 14 and 15.

Once the stabilization device 300 is coupled to the extension set 360,the stabilization device 300 can be positioned on the skin of thepatient (e.g., at or near the insertion site or target location). Inthis example, the IV catheter 350 is inserted into the hand of thepatient and thus, the stabilization device 300 is positioned relative tothe hand of the patient. Thus, the base surface 308 of the stabilizationdevice 300 can be placed in contact with the skin of the patient at ornear the insertion site of the IV catheter 350 and/or otherwise at ornear a target location of the patient. As described above, thestabilization device 300 can be adjusted and/or positioned such that therecess 310 is aligned with and/or otherwise disposed about or over thevein in which the IV catheter 350 is disposed. In this manner, securingthe stabilization device 300 to the skin of the patient does not resultin the base surface 308 exerting a force on the vein that may otherwisebe sufficient to occlude and/or restrict flow through the vein.

Having coupled the stabilization device 300 to the extension set 360 andhaving placed the stabilization device 300 in the desired position at ornear the insertion site (e.g., such that the recess 310 is aligned withor disposed over the vein in which the IV catheter 350 is disposed), theuser can secure the stabilization device 300 to the patient. Forexample, although not shown in FIGS. 14 and 15, in some instances, theuser can secure the stabilization device 300 to the target location ofthe patient via medical tape or the like. More particularly, in someinstances, a user can secure the stabilization device 300 to the targetlocation of the patient using two strips of medical tape as described indetail above with reference to the stabilization device 200 and FIGS. 8and 9. While the stabilization device 300 is described as being securedto the target location of the patient via, for example, two strips ofmedical tape, it should be understood that the stabilization device 300can be secured to the target location of the patient (e.g., skin of thepatient at or near an IV insertion site) in any suitable manner such asthose described above with reference to the stabilization device 200.Accordingly, the process of securing the stabilization device 300 to thetarget location of the patient is not described in further detailherein.

As described above, securing the stabilization device 300 to the skin ofthe patient (e.g., via the strips of medical tape 332 and 334) resultsin the stabilization device 300 and/or the medical tape securing,stabilizing, and/or substantially immobilizing the IV catheter 350relative to the patient. That is to say, the arrangement of thestabilization device 300 is such that securing the stabilization device300 and the IV catheter 350 to the skin of the patient can reduce and/orsubstantially prevent movement of the IV catheter 350 or at least an IVcatheter thereof relative to the vein in which the IV catheter is atleast partially disposed, as described in further detail herein withrespect to a specific embodiment. Moreover, the arrangement of therecess 310 along the base surface 308 is such that securing and/oradhering the stabilization device 300 to the skin of the patient doesnot exert a force on the vein in which the IV catheter 350 is disposed,thereby reducing and/or substantially eliminating any obstruction and/orrestriction otherwise resulting from such a force.

FIG. 16 is a flowchart illustrating a method 10 of using a stabilizationdevice according to an embodiment. The stabilization device can be anysuitable shape, size, and/or configuration. For example, in someembodiments, the stabilization device can be substantially similar tothe stabilization devices 100, 200, and/or 300 described above.Accordingly, the stabilization device can be used to secure and/orstabilize a vascular access device (VAD) at least partially disposed ina patient. As described above, the VAD can be any suitable device or setof devices. For example, in some embodiments, the VAD can be an IVcatheter. In other embodiments, the VAD can be an adapter or connector(e.g., an extension set) coupled to an indwelling or placed IV catheter.

As shown in FIG. 16, the method 10 includes coupling the stabilizationdevice to the VAD at least partially disposed in a vein of a patient, at11. As described above with reference to the stabilization devices 200and/or 300, the stabilization device can include a coupling surface(e.g., the coupling surfaces 212 and/or 312) configured to receiveand/or couple to a portion of the VAD. For example, in some embodiments,the VAD can include and/or can be an IV catheter that is coupled to anIV extension set or the like. As described above with reference to thestabilization devices 200 and/or 300, the extensions set can be a dualport extension set or adapter having, for example, a T-configuration orthe like. In such embodiments, the coupling of the stabilization deviceto the VAD can include placing the extension set in contact with thecoupling surface of the stabilization device such that a side port orthe like of the extension set is aligned with and/or in contact with aside channel included in and/or formed by the coupling surface (seee.g., FIGS. 7, 14, and/or 15).

In some embodiments, the coupling surface can include one or morefeatures, protrusions, members, etc. configured to selectively engage aportion of the VAD or adapter if, for example, the stabilization device,VAD, and/or adapter are in an undesirable orientation or the like, asdescribed above with reference to the coupling surface 312. For example,in some embodiments, the coupling of the stabilization device to the VADincludes coupling the stabilization device to an extension set, aligninga longitudinal axis of the extension set with a longitudinal centerlineof the stabilization device (e.g., such that the longitudinal axis andthe longitudinal centerline are co-axial, parallel, and/or otherwiseextending in a substantially similar direction), and placing theextension set in contact with the coupling surface of the stabilizationdevice. As described above, when the stabilization device and/or theextension set are in a desired orientation and/or are otherwise facingin the same direction, the side port of the extension set can be alignedwith and placed in contact with a side channel of the coupling surface.If, however, the stabilization and/or the extension set are not in adesired orientation and/or are otherwise facing in opposite directions,the features, protrusions, members, etc. of the coupling surface canengage a portion of the extension set, which in turn, can result in theside port of the extension set being misaligned relative to the sidechannel and thereby, substantially prevented from being placed incontact therewith (as described in detail above with reference to thestabilization device 300). In other embodiments, the coupling surface ofthe stabilization device need not include such a feature or the like.

After coupling the stabilization device to the VAD, the stabilizationdevice is positioned on the skin of the patient (e.g., at a targetlocation) such that a recessed portion formed by a base surface of thestabilization device is aligned with the vein, at 12. As described abovewith reference to the stabilization devices 100, 200, and/or 300, therecessed portion can be configured to reduce and/or substantiallyprevent the base surface from exerting an undesired force on the vein ofthe patient when the stabilization device is secured to the skin of thepatient. Accordingly, the position of the stabilization device relativeto the target location and/or an IV insertion site can be adjusted untilthe recessed portion is aligned with and/or disposed above or about thevein.

With the stabilization device in the desired position, a first strip ofmedical tape is applied to a proximal surface of the stabilizationdevice such that each of a first end portion and a second end portion ofthe first strip of medical tape are in contact with the target locationof the patient and are distal to a medial portion of the first strip ofmedical tape, at 13. As described above with reference to thestabilization device 200, the first strip of medical tape can be appliedto the stabilization device such that a portion of the first stripoverlays and/or is adhered to at least a portion of the proximal surfaceof the stabilization device. In some embodiments, the proximal surfaceof the stabilization device can have a size and/or shape that isconfigured to result in a bending or bowing of the first strip ofmedical tape when it is applied to the proximal surface (e.g., asdescribed above with reference to FIGS. 8 and 9). The bending and/orbowing of the first strip of medical tape, in turn, results in each ofthe first end portion and the second end portion of the medical tapebeing secured to the target location of the patient (e.g., to the skinof the patient at or near the IV insertion site) in a distal positionrelative to the proximal surface of the stabilization device. Moreover,the medial portion of the first strip of medical tape (e.g., a middleportion) is at least partially in contact with the proximal surface ofthe stabilization device and at least partially in contact with the skinof the patient at or near the target location (see e.g., FIGS. 8 and 9).

The method 10 includes applying a second strip of medical tape to aportion of the stabilization device such that the second strip ofmedical tape partially overlaps at least the first end portion and thesecond end portion of the first strip of medical tape, at 14. Forexample, as described above with reference to FIGS. 8 and 9, the secondstrip of medical tape can be applied transversely to the portion of thestabilization device such that a first end portion of the second stripof medical tape is adhered to the skin of the patient and at leastpartially overlaps the first end portion of the first strip of medicaltape; a second end portion of the second strip of medical tape isadhered to the skin of the patient and at least partially overlaps thesecond end portion of the first strip of medical tape; and a medial ormiddle portion of the second strip of medical tape is adhered to theportion of the stabilization device and/or to the extension set.Moreover, the portion of the stabilization device is distal to theproximal surface to which the first strip of medical tape is adhered. Insome embodiments, positioning a portion of the second strip of medicaltape over a portion of the first strip of medical tape can enhance theadhesion of at least one of the first strip or the second strip. Inother words, positioning a portion of the second strip of medical tapeover a portion of the first strip of medical tape can reduce alikelihood of the portion of the first strip of medical tape fromworking loose, decoupling, and/or otherwise breaking the adhesive bond.

In some embodiments, the arrangement of the first strip of medical tapeand the second strip of medical tape can be such that a proximal lockingmechanism of the extension set extends between and/or through a space,gap, and/or separation defined between, for example, the medial portionof the first strip of medical tape and the medial portion of the secondstrip of medical tape (see e.g., FIGS. 8 and 9). In other words, neitherthe first strip nor the second strip of medical tape obstructs theproximal locking mechanism of the extension set. Accordingly, anysuitable device or the like can be coupled to the proximal lockingmechanism of the extension set when the stabilization device is securedto the target location of the patient.

As described above, securing the stabilization device to the skin of thepatient at, on, or near the target location (e.g., via the strips ofmedical tape) results in the stabilization device securing, stabilizing,and/or substantially immobilizing the IV catheter relative to the targetlocation of the patient. That is to say, the arrangement of thestabilization device is such that securing the stabilization device andthe IV catheter to the skin of the patient can reduce and/orsubstantially prevent movement of the IV catheter or at least an IVcatheter thereof relative to the vein in which the IV catheter is atleast partially disposed, as described in further detail herein withrespect to a specific embodiment. Moreover, the arrangement of therecessed portion along the base surface is such that securing and/oradhering the stabilization device to the skin of the patient does notexert a force on the vein in which the IV catheter is disposed, therebyreducing and/or substantially eliminating any obstruction and/orrestriction otherwise resulting from such a force.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where schematics and/or embodiments described above indicatecertain components arranged in certain orientations or positions, thearrangement of components may be modified. Although various embodimentshave been described as having particular features and/or combinations ofcomponents, other embodiments are possible having a combination of anyfeatures and/or components from any of embodiments as discussed above.While the embodiments have been particularly shown and described, itwill be understood that various changes in form and details may be made.

In some embodiments, the specific configurations of the variouscomponents can also be varied. For example, the size and specific shapeof the various components can be different from the embodiments shown,while still providing the functions as described herein. Morespecifically, the size and shape of the various components can bespecifically selected for a desired rate and/or volume of bodily fluidflow into a fluid reservoir. Likewise, the size and/or shape of thevarious components can be specifically selected for a desired orintended usage.

Where methods and/or schematics described above indicate certain eventsand/or flow patterns occurring in certain order, the ordering of certainevents and/or flow patterns may be modified. Additionally certain eventsmay be performed concurrently in parallel processes when possible, aswell as performed sequentially.

What is claimed:
 1. A method of stabilizing a vascular access device atleast partially disposed within a vein of a patient, the methodcomprising: coupling a stabilization device to the vascular accessdevice at least partially disposed in the vein of the patient;positioning the stabilization device on a target location of the patientsuch that a recessed portion formed by a base surface of thestabilization device is aligned with the vein; applying a first strip ofmedical tape to a proximal surface of the stabilization device such thateach of a first end portion and a second end portion of the first stripof medical tape are in contact with the target location of the patientand are distal to a medial portion of the first strip of medical tape,the medial portion being at least partially in contact with the proximalsurface of the stabilization device and at least partially in contactwith the target location of the patient; and applying a second strip ofmedical tape to a portion of the stabilization device such that thesecond strip of medical tape partially overlaps at least the first endportion and the second end portion of the first strip of medical tape,the portion of the stabilization device being distal to the proximalsurface.
 2. The method of claim 1, wherein the vascular access deviceincludes an intravenous catheter at least partially disposed in the veinof the patient, the coupling of the stabilization device to the vascularaccess device includes placing a coupling surface of the stabilizationdevice in contact with an extension set coupled to a proximal hub of theintravenous catheter.
 3. The method of claim 2, wherein the extensionset has a proximal locking mechanism, a distal locking mechanism, and aside port, the extension set defines a longitudinal axis extendingthrough the proximal locking mechanism and the distal locking mechanism,the side port is substantially perpendicular to the longitudinal axis.4. The method of claim 3, wherein the coupling surface of thestabilization device includes a side channel that extends perpendicularto a longitudinal centerline of the stabilization device, the couplingof the stabilization device to the vascular access device includescoupling the stabilization device to the extension set such that (1) thelongitudinal centerline of the stabilization device is aligned with thelongitudinal axis of the extension set and (2) the side port of theextension set is placed in contact with the side channel of thestabilization device.
 5. The method of claim 1, wherein the base surfaceincludes a contoured portion and the recessed portion, the positioningof the stabilization device on the target location being such that thecontoured portion of the base surface is in contact with the targetlocation of the patient and the recessed portion of the base surface isspaced apart from the target location of the patient.
 6. The method ofclaim 1, wherein applying the first strip of medical tape to theproximal surface of the stabilization device and applying the secondstrip of medical tape to the portion of the stabilization device isoperable to secure the stabilization device to the target location ofthe patient, the stabilization device configured to stabilize thevascular access device when the stabilization device is secured to thetarget location.
 7. The method of claim 6, wherein the base surfaceincludes a contoured portion and the recessed portion, the stabilizationdevice configured to be secured to the target location of the patientsuch that (1) the contoured portion of the base surface is in contactwith and exerts a force on the target location of the patient and (2)the recessed portion of the base surface is spaced apart from and doesnot exert a force on the target location of the patient.